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Question 1. A sales rep from a licensed distributor offers to drop off a bottle of a Schedule II product at your pharmacy "as a favor," with no invoice and no order record, to tide you over a shortage. Under federal law, what is the problem?

  • A. Nothing; both parties are registered, so the transfer is lawful.
  • B. The transfer would occur outside the documented, closed system the CSA requires; every transfer must run through registered parties and be recorded.
  • C. It is lawful only if the quantity is under a 72-hour supply.
  • D. It is lawful only if you notify the state board within 7 days.
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Answer: B. The CSA builds a closed system in which every transfer of a controlled substance must move through registered parties and be documented. An undocumented handoff breaks that traceability even between two registrants. A is wrong because registration status alone does not authorize an off-the-books transfer; the documentation is the point. C invents a quantity threshold that does not exist for this rule. D invents a notification cure that does not make an undocumented transfer lawful.

Question 2. A patient you have never seen presents a Schedule II prescription. The form is complete and correctly signed, but the patient paid cash, drove past four closer pharmacies, and cannot name the condition the drug treats. What is your best action under federal law?

  • A. Fill it: the prescription contains every required element, so it is valid.
  • B. Refuse and investigate; the pattern raises doubt about legitimate medical purpose and the usual course of practice.
  • C. Fill it but report the prescriber to the DEA afterward.
  • D. Fill a 3-day supply and require the patient to return for the balance.
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Answer: B. A prescription is valid only if issued for a legitimate medical purpose in the usual course of professional practice, and the pharmacist's corresponding responsibility bars knowingly filling a doubtful order. A is wrong because a complete data set does not cure a purpose defect; form is not substance. C is wrong because you may not dispense first and investigate later when you already hold red flags; the duty is to resolve doubt before filling. D invents a partial-fill workaround the facts do not support and still dispenses a questionable order.

Question 3. A hospital pharmacist finds that a lot of injectable drug was held in a warehouse with a leaking roof and may have been contaminated by standing water. The printed labeling on each vial is complete and accurate. Under the FDCA, this drug is best described as:

  • A. Misbranded, because holding conditions are a labeling matter.
  • B. Adulterated, because it was held under insanitary conditions where it may have been contaminated.
  • C. Both adulterated and misbranded, because any violation triggers both.
  • D. Neither, because the label is accurate and complete.
Show the answer

Answer: B. Adulteration goes to the physical condition of the product; a drug held under insanitary conditions whereby it may have been contaminated is adulterated [21 USC 351(a)–(c)]. A is wrong because holding conditions affect the product, not the labeling; that is adulteration, not misbranding. C is wrong because a defect does not automatically create both violations; the facts describe a product defect only, and the labeling is accurate. D is wrong because an accurate label does not cure a contaminated product; the drug is still adulterated.

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